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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89487

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 31, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
B. Braun Medical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.

Z-0727-2022
Recall number
Z-0727-2022
Initiated
January 31, 2022
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
15,550 ea (US); 900 ea (OUS)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
contamination of the fluid path that can lead

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.

Code information

Product Code 412005 Lot Number 0061788969 Expiration date 5/31/2026 GUDID 04022495769633

Distribution pattern

US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC, NJ, OH, PA, TN, TX, and UT. The country of Canada.

Field note

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